proposed structure for master of pharmacy degree-02!09!13

8/22/2019 Proposed Structure for Master of Pharmacy Degree-02!09!13

1/90

Master in Pharmacy

Duration- 2 Years Full Time Course

(4 Semesters)

Proposed Programme Structure

Curriculum

Faculty o! Pharmaceutical Science

C " S#$# "%&'S&TY

*adh+an City


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PROPOSED REGULATIONS

FACULTY of Pharmaceutical Science

C. U. SA UNI!ERSITY"

#AD#AN


3/90

egulations !or Master in Pharmacy

(M, Pharm) Course

%ame o! Program $a%ter in Pharmac& '$. Pharm(

C. U. Shah Uni)er%it& offer% $a%ter in Pharmac& '$. Pharm( cour%e of t*o &ear% 'four

%eme%ter%( +uration in the follo*in, %-ecialiation.

/. Pharmaceutic%

0. Pharmaceutical Technolo,&

1. 2ualit& A%%urance

3. Pharmaceutical Anal&%i%

4. Pharmacolo,&

,Pharma(P.) /,Master in Pharmacy

The -o%t ,ra+uate +e,ree -ro,ram in Pharmac&" lea+in, to the +e,ree of $a%ter in

Pharmac&" i% offere+ 5& C.U.Shah Uni)er%it&.

The cour%e of %tu+& for $a%ter in Pharmac&%hall e6ten+ o)er a -erio+ of t*o aca+emic

&ear% 'four %eme%ter%(. The curricula an+ %&lla5i for the cour%e% %hall 5e a% -re%cri5e+

from time to time 5& C.U.Shah Uni)er%it&.

,Pharma (P.) 2, ligi0ility Criteria !or Master in Pharmacy$dmission

a, The %tu+ent% %ee7in, a+mi%%ion in the /%tSeme%ter of $a%ter in Pharmac& De,ree

Pro,ram %hall ha)e to -a%% the 8achelor in Pharmac& e6amination or an& other

reco,nie+ e6amination% con%i+ere+ e9ui)alent 5& the C.U Shah Uni)er%it&:

0, O)er an+ a5o)e the can+i+ate %houl+ ha)e a--eare+ the Gra+uate Pharmac& A-titu+e

Te%t 'GPAT( or an& e9ui)alent entrance e6amination finalie+ 5& the e+ucation+e-artment" Go)ernment of Gu;arat" or a% -er the amen+ment of an& rule% an+ re,ulation

5& e+ucation +e-artment Go)ernment of Gu;arat an+ C.U.Shah Uni)er%it& from time to

time.

c,oint


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A+mi%%ion Committee for Profe%%ional cour%e% '>AC?PC no* AC?PC(( con%titute+ 5& the

E+ucation De-artment" Go)t. of Gu;arat Gan+hina,ar" )i+e re%olution No. P!S @/01 @

B1 @ S +ate+ 4?4?0B *ith the commencement -u5li%he+ 5& com-etent authorit& time

5& time.

An+ 04= %eat% %hall 5e fille+ u- a% a mana,ement 9uota %eat a% -er the ,ui+eline of >AC?

PC 'no* AC?PC(.

,Pharma (P.) 1, Medium o! &nstruction amination En,li%h

,Pharma (P.) 4, nrollment o! Student

A+mi%%ion ,rante+ 5& the authorie+ committee to an& %tu+ent %hall 5e -ro)i%ional till

the enrollment i% ma+e 5& the C.U.Shah Uni)er%it&. In ca%e of a+mi%%ion en+or%e+ on the

5a%i% of -ro)i%ional eli,i5ilit& certificate" the con+ition% of the Uni)er%it& %hall 5e

com-lie+ *ithin fi6e+ time limit failin, *hich ma& lea+ to forfeitment of can+i+ature: in

*hich ca%e no fee% on an& account *ill 5e refun+e+ *hat%oe)er.

,Pharma (P.) 3, Programme composition Credits

A %tu+ent a+mitte+ to a -ro,ramme %houl+ %tu+& the cour%e% an+ earn cre+it% %-ecifie+ in

the cour%e %tructure. Plea%e refer +etaile+ %&lla5u%.

,Pharma (P.) , $ttendance

/( All Stu+ent% mu%t atten+ e)er& lecture" %eminar an+ -ractical cla%%e% o*e)er" to

account for late ;oinin, or other %uch contin,encie%" the atten+ance re9uirement for

a--earin, the e6amination% %hall 5e a minimum of


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Inter Uni)er%it& %-ort%" e+ucational tour% @ fiel+ *or7 recor+" +ul& counter%i,ne+ 5&

the Officer In char,e" i% %ent for +ue con%i+eration to the Dean of Facult& *ithin t*o

*ee7% of the function @ acti)it&" etc.

3( No e6em-tion *ill 5e ,i)en to an& %tu+ent from atten+ance e6ce-t on account of%eriou% -er%onal illne%% or acci+ent or famil& calamit& that ma& ,enuinel& -re)ent a

%tu+ent from atten+in, a -articular %e%%ion or a fe* %e%%ion%. o*e)er" %uch

une6-ecte+ a5%ence from cla%%e% an+ other acti)itie%" ma6imum one month *ill 5e

re9uire+ to 5e con+one+ 5& the Princi-al or authoritie%.

4( .rant o! Terms The can+i+ate *ill 5e ,rante+ a term -ro)i+e+ he@%he ha%

%ati%factoril& com-lete+ the -re%cri5e+ cour%e of %tu+& ha% 7e-t ournal Clu5 acti)itie% etc.

,Pharma (P.) 5, 6aluation Systems

The -erformance of e)er& %tu+ent in each %u5;ect *ill 5e e)aluate+ a% follo*%

B( Internal e)aluation *ill 5e of 1= mar7% for the each %u5;ect.


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total 1 mar7% '%e%%ional( %hall 5e allotte+ a% -er follo*in,

i. Actual -erformance of -ractical e6amination ??0mar7%

ii. Da& to Da& atten+ance@Pro;ect *or7@%eminar@a%%i,nment@)i)a?)oice" etc. ??/mar7%

c,The +uration of internal e)aluation %hall 5e con+ucte+ for /.4 hour% for 1 mar7% of

theor& '/ hr for /4 mar7% of theor&( an+ B hour% for -ractical e6amination.

d, emedial eamination and8or continuous e6aluation If the can+i+ate +o not

%ecure+ 3 = mar7% in internal e6amination of theor& or -ractical" he@%he mu%t a--ear in

reme+ial e6amination an+ the ma6imum internal mar7% *ill 5e not more than 3=.

e@%he %hall 5e allo*e+ to a--ear onl& one reme+ial e6amination

,Pharma (P.) 9, ternal e6aluation (nd semester eamination)

The e6ternal e)aluation *ill 5e hel+ 5& the Uni)er%it& for


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The Pro;ect Re-ort -re-are+ accor+in, to a--ro)e+ ,ui+eline% an+ +ul& %i,ne+ 5& the

%u-er)i%or'%( an+ the ea+ of the De-artment %hall 5e %u5mitte+ to the ea+ of the

In%titution,

Progress of dissertation work

( Di%%ertation *or7 %hall 5e carrie+ out un+er the %u-er)i%ion of facult& mem5er in the

concerne+ +e-artment an+ the *or7 -ro,re%% to 5e maintaine+ in the -re%cri5e+ *or7

+air& an+ recor+ 5oo7. The *or7 +iar& an+ recor+ 5oo7 %hall 5e )erifie+ an+ certifie+

5& the ea+ of the De-artment an+ ea+ of the in%titution. The certification of

%ati%factor& -ro,re%% i% 5a%e+ on the *or7 +iar& an+ recor+ 5oo7.

Evaluation of dissertation work

/( Each an+ e)er& can+i+ate ha% to %u5mit t*o time% ei,ht to ten -a,e% -ro,re%% re-ort

*ith -re%entation +urin, the %eme%ter?III an+ Seme%ter?I!. The %-ecific *ei,hta,e i%

,i)en to each -re%entation.

//( The +i%tri5ution of *ei,hta,e of the )ariou% com-onent% of e)aluation for +i%%ertation

*or7 %hall 5e a% follo*%

a( Re%earch Pro,re%% A%certainin, '0 time%( /4 =

5( Re%earch Pro;ect Pre%entation '$i+ Term( /4 =

c( !i)a?!oice 'Uni)er%it& E6amination(


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%ecure o)erall 4= mar7%. If he@%he o5tain le%% than 3= 'internal an+ e6ternal( mar7% %o

he@%he i% faile+ in -articular %u5;ect *hich *ill 5e con%i+ere+ a% a 5ac7lo, 'F(.

,Pharma (P.) /2,


9/90

/1( S.P$ > ?Ci.i 8 ?Ci

#here"

Ci i% the num5er of cre+it% of %u5;ect 'i(

Gi i% the Gra+e Point for the %u5;ect 'i(

i / to n"

n num5er of %u5;ect in the %eme%ter

/3( C.P$ > ?Ci.i 8 ?Ci

#here"

Ci i% the num5er of cre+it% of %u5;ect 'i(

Gi i% the Gra+e Point for the %u5;ect 'i(

i / to n" n num5er of %u5;ect of all %eme%ter%

u-to *hich CGPA i% com-ute+

,Pharma (P.) /4, $+ard o! Degree

E)er& can+i+ate of the -ro,ram *ho fulfil% the follo*in, criteria *ill 5e eli,i5le forthe

a*ar+ of the +e,ree

e@She %houl+ ha)e cleare+ all en+ %eme%ter an+ o)erall e)aluation% com-onent% ine)er&

%u5;ect: an+ he@%he %houl+ ha)e %ecure+ a minimum CGPA of B. at the en+ of the

-ro,ramme. In a++ition to a5o)e" the %tu+ent ha% to com-lete the re9uire+ formalitie% a%

-er the re,ulator& 5o+ie%" if an&. The %tu+ent *ho fail% to %ati%f& minimum re9uirement

of CGPA *ill 5e allo*e+ to im-ro)e the ,ra+e% %o a% to %ecure a minimum CGPA for

a*ar+ of +e,ree. Onl& late%t,ra+e *ill 5e con%i+ere+.

,Pharma (P.) /3, $+ard o! Class

A cla%% *ill 5e a*ar+e+ onl& after -a%%in, the final %eme%ter e6amination '3 th%eme%ter


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e6amination(. A %tu+ent *ill 5e +eclare+ to -a%% the final e6amination lea+in, to a*ar+ of

+e,ree of $a%ter in Pharmac& a% -er 5elo* mention ta5le -ro)i+e+ he@%he -a%%e% the

e6amination in all the concerne+ %u5;ect% in each %eme%ter%.

The cla%% a*ar+e+ to a %tu+ent in the -ro,ram i% +eci+e+ 5& the final CGPA a% -er the

follo*in, %cheme

Di%tinction CGPA K


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First Semester M, Pharm ($ll Disciplines)

Teaching Scheme

(#ours8*ee;)

Theory

Sessional am "ni6ersity

Mar;s #rs Mar;s #

/ PG$P//@ PG$P//P $o+ern Anal&tical Techni9ue% 3 ? B / / 1 /.4


12/90

P@P@SD ST"CT" F@ M$ST &% P#$M$CY D. (M,

Pharm)

C, ", S#$# "%&'S&TYA *$D#*$% C&TY

Second Semester M, Pharm ($ll Disciplines)

Teaching Scheme

(#ours8*ee;)

Theory

Sessional

Exam

University Ex

Marks Hrs Marks Hr

/ PG$P0/ Dru, Re,ulator& A%-ect% IPR 3 ? ? 3 3 1 /.4


13/90

P@P@SD ST"CT" F@ M$ST &% P#$M$CY D. (M,

Pharm)

C, ", S#$# "%&'S&TYA *$D#*$% C&TY

Third Semester M, Pharm ($ll Disciplines)

Teaching Scheme

(#ours8*ee;)

Theory

Sessional

Exam

University Ex

Marks Hrs Marks Hr

/ PG$P1//@11/@13/@14/

PG$P1//P@11/P@13/P@14/P

S-ecialiation?! 3 0 B /0 /0 1 /.4


14/90

Sessional

Exam

University Ex

Marks Hrs Marks Hr

/ PG$P3/ Di%%ertation Pha%e?II ? ? 1 1 1 ? ? ? ?

- - 1: 1: 1: - -

%ote- T in+icate%TheoryB S in+icate%SeminarB and P in+icate%Practical

C " S#$# "%&'S&TY *$D#*$% C&TY

%ame o! the Program $a%ter in Pharmac& 'All Di%ci-line(

Total Credits accumulated at the end o! the program //B

Semester Credits

First 1:

Second 2

Third 1:

Fourth 1:

Total Credits earned at the end o! the

Program//


15/90

C " S#$# "%&'S&TY *$D#*$% C&TY

%ame o! the Program $a%ter in Pharmac& 'All Di%ci-line(

Total Mar;s accumulated at the end o! the program 73::$ar7%

Sr.

N

o

Sem?

e%terTheor& Practical

Pro;ect #or7

'Di%%ertation(

Total

$ar7%

Inter

nal

Mark

s

Exter

nal

Mark

s

Total

Mark

s

Inter

nal

Mark

s

Exter

nal

Mark

s

Total

Mark

s

Inter

nal

Mar

ks

Exter

nal

Mark

s

Total

Mark

s

1 First 105 245 350 60 140 200 - - - 550

2Seco

nd120 280 400 30 70 100

- - -500

3 Third 30 70 100 30 70 100 60 140 200 400

4Fort

h- - - - - -

!0 210 300300

Total Marks

o" Theor#

Exa$ination

850

Total Marks

o" %ractical

Exa$ination

400

Total Marks

o" %ro&ect

'ork

500 1750


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C " S#$# "%&'S&TY

*$D#*$% C&TY

%ame o! Faculty Pharmaceutical Science

Proposed Sylla0i !or

Master in Pharmacy

Semester-&

%ame o! Discipline

/4( Pharmaceutics

/B( Pharmaceutical Technology

/


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%ame o! Su0ect $o+ern Anal&tical Techni9ue% 'Theor&(

Su0ect Code PG$P//

T$C#&%. '$E"$T&@% SC#M-

Teaching Scheme

(#ours8*ee;)

Theory

Sessional

Exam

University

Exam

Marks Hrs Marks Hr

/PG$P//

$o+ern Anal&tical Techni9ue% 3 ? B / / 1 /.4


18/90

inclu+in, multi?com-onent a%%a& an+ +eri)ati)e %-ectra. #oo+*ar+?Fie%er an+

Fie%er?uhn rule% for calculatin, a5%or5ance ma6imum an+ inter-retation of %-ectra.

2 &n!rared spectroscopyIntro+uction" 5a%ic -rinci-le%" in%trumentation 'com-onent%

an+ their function(" %am-lin, techni9ue%" inter-retation of %-ectra an+ a--lication%.

Theor& an+ a--lication% of FTIR"ATR an+ NIR.

B

3 %uclear Magnetic esonance SpectroscopyFun+amental -rinci-le an+ theor& of

-roton N$R" in%trumentation" %ol)ent%" chemical %hift" %-in?%-in cou-lin," cou-lin,

con%tant" %-in?%-in +ecou-lin," -roton e6chan,e reaction%" %im-lification of com-le6

%-ectra" FT? N$R" 0D?N$R" a--lication% in -harmac& an+ inter-retation of %-ectra.

/1C N$R S-ectro%co-& Pea7 a%%i,nment%" off re%onance +ecou-lin," %electi)e

-roton +ecou-lin," chemical %hift e9ui)alence" chemical %hift% an+ %-in cou-lin, an+

it% %tructural a--lication%.

/

4 Mass Spectroscopy8a%ic -rinci-le an+ in%trumentation" ion formation an+ t&-e"

fra,mentation -roce%% an+ fra,mentation -attern" chemical ioniation ma%%

%-ectro%co-& 'CI$S(" fiel+ ioniation $S 'FI$S(" Fa%t atom 5om5ar+ment $S

'FA8?$S(" matri6 a%%i%te+ la%er +e%or-tion@ ioniation $S '$ALDI?$S("

Inter-retation of %-ectra an+ a--lication in -harmac&" Surface Ioniation $S'SI$S(.

5 @ptical otary Dispersion Princi-le" Plain cur)e%" cur)e% *ith cotton effect"

octant rule an+ it% a--lication% *ith e6am-le" circular +ichroi%m an+ it% relation to

ORD.

1

6 Thermal Methods o! $nalysis Thermoanal&tical techni9ue% Differential

Scannin, Calorimetr& 'DSC(" Thermo,ra)itr& 'TG(" Thermo mechanical anal&%i%

'T$A( Princi-le% in%trumentation an+ a--lication% 'inclu+in, inter-retation of +ata(

in -harmac&.

1

7 Chromatographic techniHuesCla%%ification of chromato,ra-hic metho+% 5a%e+

on mechani%m of %e-aration. Theorie% of chromato,ra-hic %e-aration. Princi-le%"

elution techni9ue%" in%trumentation" +eri)atiation an+ a--lication of GC" PLC"PTLC. Princi-le%" elution techni9ue%" a--lication% of ion e6chan,e an+ ion -air

chromato,ra-h&" affinit& chromato,ra-h&" Sie e6clu%ion chromato,ra-h&" chiral

chromato,ra-h&" %u-er flui+ chromato,ra-h& 'SFC("UPLC" GC?$S" %hort column

chromato,ra-h&" fla%h chromato,ra-h&" me+ium -re%%ure LC an+ LC?$S.

/


19/90

8 adio analytical techniHues used in pharmaceuticals I%oto-ic +ilution metho+%"

Ra+ioimmunoa%%a&" ELISA etc.

0

! lectrophoresis Theor& an+ -rinci-le%" cla%%ification%" in%trumentation" mo)in,

5oun+ar& electro-hore%i%" Mone Electro-hore%i% 'ME(" I%oelectric focu%in, 'IEF( an+

a--lication%.

0

10 ())lication o" Trans$ittance Electron Microsco)# *TEM+ and

Scannin, Electron Microsco)# *SEM+

0

Total B


20/90

C. U. SA UNI!ERSITY

#AD#ANCITY

Faculty ? Pharmaceutical Science%

Department All Di%ci-line

Semester &

%ame o! Su0ect $o+ern Anal&tical Techni9ue% 'Practical(

Su0ect Code PG$P//P

Module-/ U!@!i%i5le %-ectrum %cannin, of a fe* or,anic com-oun+% for U!? a5%or-tion an+

correlation% of %tructure% an+ i%o%5e%tic -oint in ca%e of mi6ture%.

Module-2 Effect of %ol)ent% an+ - on U! %-ectrum of +ru,%

Module-1 Simultaneou% e%timation of com5ination formulation% 'minimum of 3 e6-eriment%(

e.,. !itamin%" Oral anti+ia5etic%" NSAID%" Antimicro5ial%" Antihi%tamine%" Antih&-erten%i)e etc.

Module-4 E6-eriment% 5a%e+ on the a--lication of +eri)ati)e %-ectro%co-&.

Module-3 E6-eriment% 5a%e+ on PLC 'I%ocratic an+ Gra+ient elution( techni9ue%.

Module- Inter-retation of +ru,% 5& IR %-ectra

Module-5 #or7%ho- of %-ectro%co-& 'U!" IR" N$R" $ASS( %tructural eluci+ation of fe*

com-oun+%

Module-7 Se-aration of -rotein +ru, %u5%tance% 5& electro-hore%i%

Module-9 U%e of fluorimeter for anal&%i% of Pharmaco-oieal com-oun+%.

Module-/: E6-eriment% of Chromato,ra-h&. 'a( Thin La&er Chromato,ra-h&" '5( Pa-er

Chromato,ra-h&.

Module-// An& other rele)ant e6-eriment% 5a%e+ on theor&.


21/90

E$%&%. @"TC@MS-

0


22/90

1ame%" >. Lear&" 3th

E+ition.

3


23/90

4/( Techni9ue% an+ Practice of Chromato,ra-h& Ra&mon+ P. #. Scott" !ol.


24/90

Marks Hrs Marks Hr

/PG$P/0

8io%tati%tic% 0 ? ? 0 0 /4 / 14 0

@


25/90

:3 perimental design in clinical trialsB

Parallel an+ cro%%o)er +e%i,n%. Stati%tical te%t for 5ioe9ui)alence. Do%e re%-on%e

%tu+ie%

:4

: &ntroduction to common so!t+are :/

Total 1:

E$%&%. @"TC@MS

B3( Stu+ent% *ill a5le to i+entif&" anal&e an+ %ol)e -ro5lem% relate+ to 5io%tati%tic%

u%in,

%tati%tical %oft*are.

B4(Stu+ent% can a--l& 5io%tatic% a--lication in or+er to un+er%tan+ )ariou%

-harmaceutical -roce%% )aria5le%" un+er%tan+ %i,nificance effect on -arameter% in

clinical trial%

T$C#&%. E$%&%. MT#@D@[email protected]

BB( Lecture% *ill 5e ta7en in cla%% room *ith the ai+ of multi?me+ia -re%entation% @

5lac7 5oar+ or mi6 of 5oth.

Bohn #ile&.


26/90


27/90

Sessional

Exam

University

Exam

Marks Hrs Marks Hrs

/

PG$P///

Fun+amental of Formulation

Pro+uct De)elo-ment

3 0 B /0 /0 1 /.4


28/90

of -ol&mor-hi%m on %olu5ilit& an+ +i%%olution rate" effect of

-harmaceutical -roce%%in, on +ru, -ol&mor-h% an+ %ol)ate%" im-act

of -ol&mor-hi%m on 9ualit& of l&o-hilie+ -ro+uct%.

:1 Partition Coe!!icient

Pharmaceutical %i,nificance of -artition coefficient" correlation *ith

in?)i)o

-erformance" techni9ue% to e%timate lo, P )alue%" %ha7e fla%7

metho+" choice of %ol)ent %&%tem%" chromato,ra-hic +etermination"

theoretical com-utation u%in, an%ch Leo@Re77er -rinci-le" effect

of )ariou% )ariant% li7e tem-erature" -" etc. on -artition coefficient.

:3

:4 cipients

General con%i+eration% of e6ci-ient% u%e+ in formulation% an+

factor% ,o)ernin, %election.

Compati0ility issues regarding ecipients +ru,?e6ci-ient% an+

e6ci-ient e6ci-ient" e6ci-ient%?-ac7a,e interaction%

Sa!ety and regulatory issues o! ecipients

&nternational patented ecipients, Im-lication of 9uantitati)e

%election of each e6ci-ient in -ro+uct +e)lo-ment.

Study o! no6el ecipients

Su-er+i%inte,rant%" +irectl& com-re%%i5le an+ %-ra& +rie+ +iluent%"

film coatin, material%" %olu5iliin, a,ent% li7e %urfactant%" C&clic

Gluco%e Pol&mer%" -ol&meric e6ci-ient% for controlle+ relea%e

a--lication%" Im-ro)e+ e6ci-ient% functionalit& 5& co -roce%%in,"

Stan+ar+iation of e6ci-ient%

:7

:3


29/90

*ith reference to c&clo+e6trin%" t&-e% of c&clo+e6trin%" their

-harmaceutical a--lication% an+ chemical mo+ification%.

:5 Dissolution itKs testing

(a) Im-ortance" o5;ecti)e%" e9ui-ment%"

(0) 8iolo,ical cla%%ification %&%tem '8CS(: it% %i,nificance on

+i%%olution %tu+& an+ a--lication in +o%a,e form +e)elo-ment.

(c) Selection of +i%%olution me+ia an+ con+ition%.

(d) Com-ari%on of +i%%olution -rofile 5& mo+el in+e-en+ent

'%imilarit& an+ +i%%imilarit& factor( an+ +e-en+ent metho+%.

:7

:7 Sta0ility o! drug dosage !orms

Q De,ra+ation of +ru, in %oli+ %tate %oli+ +o%a,e form%"

%ta5iliation metho+%" im-ortance of %ta5ilit& in+icatin, a%%a& in

%ta5ilit& e)aluation" %ta5ilit& e)aluation of +i%-er%e %&%tem%.

Q 8rief intro+uction to FDA an+ #O ,ui+eline%. Detail %tu+& of

IC ,ui+eline% '2/A" 'R0(" 2/8" 2/C" 2/D" 2/E" 2/F" 24C(.

Q inetic -rinci-le% a--lie+ for %ta5ilit& e)aluation an+ their

a--lication% in -re+ictin, %helf life an+ half life of -harmaceutical

formulation%. Im-ortance of accelerate+ %ta5ilit& %tu+&.

:7

:9 #er0al Product De6elopment

8ac7,roun+ an+ -re%ent %cenario" formulation con%i+eration%" ma;orhur+le% an+ challen,e%" future -ro%-ect%.

:1

/: Documentation

Im-ortance of +ocumentation" %tatutor& re9uirement% an+ -roce+ure

for +ocumentation" critical e6amination of +ocument%.

:3


30/90

C. U. SA UNI!ERSITY

#AD#ANCITY


Department Pharmaceutic% Pharmaceutical Technolo,&

Discipline /. Pharmaceutic%

0. Pharmaceutical Technolo,&

Semester &

%ame o! Su0ect Fun+amental of Formulation Pro+uct De)elo-ment'Practical(

'S-ecialiation?I(

Su0ect Code PG$P///P

Detailed Sylla0us (Practical)To illu%trate the to-ic% inclu+e+ un+er theor&

E$%&%. @"TC@M

0( To +e)elo- the a5ilit& to effecti)el& a--l& 7no*le+,e of e6ci-ient%" +o%a,e form%"

-reformulation" 9ualit& im-ro)ement%" an+ +ocumentation of -harmaceutical

-ro+uct% an+ +ru, +eli)er& %&%tem%.


1( Throu,h +i%cu%%ion in a cla%%?room" an+ -erformin, e6-eriment% relate+ to

Pro+uct +e)elo-ment %tu+ie%.


31/90


32/90

*$D#*$%C&TY


Department Pharmaceutic% Pharmaceutical Technolo,&

Discipline /. Pharmaceutic%

0.

Pharmaceutical Technolo,&

Semester &

%ame o! Su0ect 8io-harmaceutic%" Pharmaco7inetic% $etho+% in

Dru, E)aluation 'Theor&(

'S-ecialiation?II(

Su0ect Code PG$P//0

Teaching 6aluation Scheme-

Teaching Scheme

(#ours8*ee;)

Theory

Sessional

Exam

University

Exam

Marks Hrs Marks Hrs

/

PG$P//0

8io-harmaceutic%"

Pharmaco7inetic% $etho+%

in Dru, E)aluation

3 0 ? B B 1 /.4


33/90


34/90

4 Determination of )ariou% -harmaco7inetic -arameter%

5 A5%or-tion rate con%tant" elimination rate con%tant" 5iolo,ical half

life" = +ru,

6meta5olie+" a--arent )olume of +i%tri5ution" e6cretion ratecon%tant" Clearance ' inclu+in, the conce-t of renal non?renal

clearance(" inetic% of -rotein 5in+in, an+ other Pharmaco7inetic

-arameter%

7 Soft*are% u%e+ for +etermination of -harmaco7inetic -arameter%

Pharmaco;inetics o! Multiple Dosing

8 A+;u%tment of +o%a,e in renal he-atic im-airment"

in+i)i+ualiation of thera-&" thera-eutic +ru, monitorin," inetic%

of %u%taine+ relea%e

03 %on-linear Pharmaco;inetics

Cau%e% of non?linearit&" e%timation of )ariou% -arameter% an+

5ioa)aila5ilit& of +ru,% that follo* non?linear 7inetic%

0

04


35/90

0! ai%*al" !alla5h Pra7a%han Pitam-ura" Delhi.

3. Clinical Pharmaco7inetic%" Conce-t% an+ A--lication%" $. Ro*lan+ an+ T. N. Toer"

Li--incott #illiam% #il7in%" Phila+el-hia


36/90

4. 8io-harmaceutic% an+ Clinical Pharmaco7inetic%? An intro+uction: Ro5ert. E. Notari"

$arcel De77er Inc" Ne* Yor7

B. Enc&clo-e+ia of Pharmaceutical Technolo,&" >ame% S*ar5ric7 an+ C.8o&lan" $arcel

De77er Inc" Ne* Yor7"


37/90

00. Dru, 5io%creenin, +ru, e)aluation techni9ue% in -harmacolo,&" Emmanuel 8.

Thom-%on" /" !C -u5li%her.

01. Dru, a5%or-tion %tu+ie% in %itu" in )itro an+ in %ilico mo+el%" 8& Car%ten Ehrhar+t"

*an,?>in im" 0.

-S@"CS-

/. ***.f+a.,o)

0. htt-@@***.ich.or,

C. U. SA UNI!ERSITY

#AD#ANCITYFaculty ? Pharmaceutical Science%

Department Pharmaceutical Chemi%tr& Pharmaceutical Anal&%i%

Discipline 2ualit& A%%urance '2.A(

Semester &

%ame o! Su0ect $etho+ of Dru, E)aluation Clinical Re%earch 'Theor&(

'S-ecialiation?I(

Su0ect Code PG$P/1/


Teaching Scheme

(#ours8*ee;)

6al

Theory

Sessional

Exam

University

Exam

Mark

s

Hrs Marks Hrs

/

PG$P/1/$etho+ of Dru, E)aluation

Clinical Re%earch

3 0 B /0 /0 1 /.4


38/90

/( To im-art 7no*le+,e a5out official @ non?official metho+% of e)aluation for a *i+e ran,e

of -harmaceutical +o%a,e form%

0( To ,i)e *i+e e6-o%ure to %tu+ent% in the area of Ne* Chemical Entit& -re?clinical

e)aluation% relate+ area%

1( To ,i)e them trainin, in carr&in, out %ome of the%e techni9ue% in the la5orator&

P"&S&TS-

3( At lea%t t*o cour%e% each in Pharmaceutic% 5iolo,& @ micro5iolo,& or relate+

5iolo,ical %u5;ect% at UG le)el

4( A 8. Pharm. +e,ree from an& in%titution a--ro)e+ 5& AICTE or it% e9ui)alen

C@"S @"TE&%-

Sr, %o Course Content #ours

/ 8iolo,ical Stan+ar+iation General Princi-le%" Sco-e

limitation% of 8ioa%%a&% 8io? a%%a&% of %ome Official Dru,%.

3

2 Sterilit& Te%t% $etho+olo,& Inter-retation. 3

1 P&ro,en ? chemi%tr& an+ -ro-ertie% of 5acterial -&ro,en% an+

en+oto6in%.$echani%m% of action of -&ro,en%. Pharmaceutical

a%-ect%" -&ro,en te%t of IP com-are+ to that of 8P USP.

Inter-retation of +ata" Com-ari%on of LAL an+ other -&ro,en

te%t%.

4

4 Anal&%i% of +ru,% from 5iolo,ical %am-le% inclu+in," %election of

5iolo,ical %am-le" e6traction of +ru,% 5& )ariou% metho+% a% LLE"

SPE an+ $em5rane filtration.

4


39/90

3 $icro5iolo,ical Limit Te%t%" Te%t% for effecti)ene%% of

antimicro5ial -re%er)ati)e%.

B

Ra+io immunoa%%a& General -rinci-le%" %co-e an+ limitation%"

ra+io immunoa%%a& of %ome +ru,% li7e in%ulin" +i,itali% etc.

3

5 Preclinical Dru, E)aluation" acute" %u5 acute an+ chronic to6icit&

%tu+ie%" LD4 ED4 +etermination" e)aluation of com-oun+ for

it% 5iolo,ical acti)it&" %tu+& of %-ecial to6icitie% li7e terato,enicit&

an+ muta,enicit&.

ur, Seiler" S-rin,er Ne* Yor7.

/31( Goo+ La5orator& Practice an+ Re,ulator& I%%ue%" P. !. $ohanan"

E+ucational 5oo7 centre" $um5ai

-S@"CS-

/33( ***.ich.or,@-ro+uct%@,ui+eline%@Huality.html

/34( ***.*erum.+e@en@,5@file+o*n@file+o*n+5.;%-V...@[email protected]..

/3B( indiagl#.gov.in/

/3


46/90

'S-ecialiation?I(

Su0ect Code PG$P/3/


Teaching Scheme

(#ours8*ee;)

6alu

Theory

Sessional

Exam

University

Exam

Mar;s #rs Mar;s #rs

/

PG$P/3/A+)ance Anal&tical

Techni9ue%

3 0 B /0 /0 1 /.4


47/90

0, Electron %-in re%onance %-ectro%co-&

c, Atomic a5%or-tion %-ectro%co-& an+ metal e%timation 5&

AAS1 A +etaile+ %tu+& of the -rinci-le%" in%trumentation% an+ a--lication% in

+ru, anal&%i% of GC?$S" LC?$S *ith reference to 9uantification of

+ru,% in 5iolo,ical %am-le%.

/:

4 Princi-le" in%trumentation" a--lication% an+ a+)ance +e)elo-ment of

follo*in, %e-aration techni9ue%.

a, Ca-illar& electro-hore%i%

0, Counter current chromato,ra-h&

3

3 Princi-le" *or7in, an+ +ifferent t&-e% of LASER an+ Particle %iin, 5&

la%er +iffraction e9ui-ment

4

A+)ance +e)elo-ment in i,h -erformance li9ui+ chromato,ra-h&

li7e UPLC" Nano LC" Column %*itchin," Ra-i+ re%olution LC" etc.

1

5 Princi-le" in%trumentation an+ a--lication of follo*in, anal&tical

techni9ue% *ith a--lication of the %ame in )ariou% +ru, an+ +ru,

formulation a% -er IP

A. Fluore%cence %-ectro%co-&

8. Non a9ueou% titration%C. Potentiometric titration%

9

7 Automate+ anal&%i% 2

9 $icro5iolo,ical limit te%t 1

/: Sterilit& te%tin, 1

Total :


48/90

C. U. SA UNI!ERSITY

#AD#ANCITY


Department Pharmaceutical Chemi%tr& Pharmaceutical Anal&%i%

Discipline Pharmaceutical Anal&%i%

Semester &

%ame o! Su0ect A+)ance Anal&tical Techni9ue% 'Practical(

'S-ecialiation?I(

Su0ect Code PG$P/3/P

Detail sylla0us (Practical)

/4( Anal&%i% of +ifferent formulation of +ru,% u%in, flourimetr&" non a9ueou%

titration" -otentiometr& a% -er IP

/4/( Sterilit& te%tin, of +ifferent %terile mar7ete+ -re-aration%

/40( $icro5iolo,ical limit te%t a% -er IP

/41( PLC anal&%i% of API an+ Formulation% a% -er IP

/43( Electro-hore%i% of Amino aci+ an+ %erum -rotein%

/44( 2C te%t of ta5let% a% -er IP

E$%&%. @"TC@MS-

/4B( At the en+ of the cour%e" the %tu+ent *ill 5e a5le to un+er%tan+ the fun+amental

conce-t of mo+ern anal&tical techni9ue%" *hich i% im-ortant for 9ualitati)e a% *ell a%

9uantitati)e anal&%i% of +ru, %u5%tance% an+ +ru, -ro+uct.


/4


49/90

Practical +emon%tration% an+ Practical *or7in,.

ame% #. $un%on

0/.

/4( A te6t 5oo7 of Pharmaceutical anal&%i% 5& .A.Conner% '>ohn #ile&(

/B( Lena Ohanne%ian an+ Anthon& >. Streeter" an+ 8oo7 of Pharmaceutical

Anal&%i%"

/B/( Pharm Sci. %erie%" !ol. //


50/90

C. U. SA UNI!ERSITY

#AD#ANCITY


Department Pharmacolo,& To6icolo,&

Discipline Pharmacolo,&

Semester &

%ame o! Su0ect $olecular Pharmacolo,& 'Theor&(

'S-ecialiation?I(

Su0ect Code PG$P/4/


Teaching Scheme

(#ours8*ee;)

Theory

Sessional

Exam

University

Exam

Mar;s #rs Mar;s #rs

/PG$P/4/

$olecular Pharmacolo,& 3 0 B /0 /0 1 /.4


51/90

C@"S @"TE&%-

Sr, %o Topic #rs

1 Molecular mechanism o! drug action

Rece-tor %tructure" Si,nal tran%+uction mechani%m" Termination of

rece-tor acti)it&" Rece-tor malfunction" Ra+io li,an+ 5in+in, %tu+ie%"

Dru, rece-tor interaction" Do%e re%-on%e relation%hi-" Potenc&"Efficac&

an+ Anta,oni%m%

/

2 Pharmacology o! receptors

Cla%%ification" cellular %i,nalin, %&%tem%" a%%ociate+ +i%ea%e% an+

a+)ance% in -harmacolo,& of the follo*in, rece-tor t&-e%

1 E6citator& amino aci+ rece-tor"

2 Do-amine Rece-tor"

3 N$DA Rece-tor"

4 GA8A an+ 8eno+iae-ine Rece-tor"

5 Puriner,ic Rece-tor"

6 Gl&cine Rece-tor"

7 Canna5inoi+% Rece-tor"

8 O-ioi+ Rece-tor%"

9 Imi+aoline Rece-tor

/4

3 Pharmacology o! Channels

1 So+ium channel"

2 Potta%ium channel"

3 Chlori+e channel an+

4 Calcium channel%

B

4 ndogenous


52/90

2 En+othelin

3 Pho%-ho+ie%tra%e En&me an+ Protein ina%e C

4 En+or-hin%

5 Neurotro-in%

5 Pharmacology o! %europeptides

8iolo,ical function%" -harmacolo,ical im-lication%" their rece-tor%

%&%tem% an+ thera-eutic -otential% of

1 Neuro-e-ti+e Y

2 Cholec&%to7inin

3 Tach&7inin% 'Su5%tance P@ Neuro7inin(

4$elanocortin% ' Al-ha $S(

5 Cortcotro-hin relea%in, factor

6 Ar,inine )a%o-re%%in

7 Cocaine Am-hetamine Re,ulator& Tran%cri-t ' CART(

8 Calcitonin ,ene?relate+ -e-ti+e 'CGRP(

/0

6 Cyto;ines Chemo;ines

Cla%%ification" -h&%iolo,&" -harmacolo,&" -atholo,ical" an+ thera-eutic

im-lication% of

1 Tumor necro%i% factor 'TNF?W("

2 Interferon%"

3 Interlu7ine% 'IL("

4 A+he%ion molecule%"

5 Gro*th factor%

4

7 $poptosis and %ecrosis

$olecular 5iolo,&" -h&%iolo,ical an+ -harmacolo,ical im-lication% an+

thera-eutic -otential% of a-o-to%i%.

4

Total B


53/90

C. U. SA UNI!ERSITY

#AD#ANCITY




Semester &

%ame o! Su0ect $olecular Pharmacolo,& 'Practical(

'S-ecialiation?I(

Su0ect Code PG$P/4/P

Detail Sylla0us (Practical)

/


54/90

Facult& mem5er% %hall e6-lain in a cla%% room u%in, 5lac7 5oar+ an+ multime+ia

-ro;ector.

ournal Tren+% in Pharmacolo,ical %cience%.

/1( Ganon, #illiam% F." Re)ie* of me+ical Ph&%iolo,&

/3( Paul L. $un%on" Princi-le% of Pharmacolo,&.

/4( >ame% Cro%%lan+" Le*i%J% Pharmacolo,& Churchil Li)in,%tone.

/B( $. N. Gho%h" Fun+amental% of E6-erimental Pharmacolo,& 3th E+. ilton

/


55/90

C. U. SA UNI!ERSITY

#AD#ANCITYFaculty ? Pharmaceutical Science%



Semester &

%ame o! Su0ect A+)ance+ Pharmacolo,&?I 'Theor&(

'S-ecialiation?II(

Su0ect Code PG$P/40


Teaching Scheme

(#ours8*ee;)

Theory

Sessional

Exam

University

Exam

Mar;s #rs Mar;s #rs

/ PG$P/40 A+)ance+ Pharmacolo,&?I 3 0 ? B B 1 /.4


56/90

The s/&ect shold ,ie e$)hasis on recent trends and

adances in )har$acolo,# o" "ollo'in,s

1 $utocoids i%tamine" Serotonin" Pro%ta,lan+in%" Leu7otriene%" Throm5o6ane"

PAF" An,ioten%ine" inin%" Su5%tance P" Cholec&%to7inin

/

2 P%S Pharmacology S&m-athomimetic%" S&m-athol&tic%"

Para%&m-athomimetic%" Para%&m-athol&tic%" Gan,lion 8loc7er% an+ Stimulator"

Neuromu%cular 8loc7er% an+ Acti)ator%" General an+ Local Ane%thetic%

/

3 Chemotherapy Intro+uction to Infectiou% Di%ea%e%" Princi-le% of

Chemothera-&" $ana,ement of Infectiou% Di%ea%e%" Penicillin%" Ce-halo%-orin%"

Sul-honami+e%" $acroli+e%" Amino,l&co%i+e%" 2uinolone%" Tetrac&cline"

Chloram-hanicol" Chemothera-& of Tu5erculo%i% an+ Le-ro%&" Antifun,al

a,ent%" Anti?)iral a,ent%" Anti?-rotooal a,ent%" Anthelmintic%" Chemothera-&

of Se6uall& Tran%mitte+ Di%ea%e 'STD(" Recent a+)ance% in Cancer

0

4 &mmunopharmacology Intro+uction to Immunit&" Immuno%timulant%"immuno%u--re%%ant%

B

5 Stem Cell Therapeutics 8iolo,& of %tem cell% an+ their -otential% in )ariou%

+i%ea%e%

ame% Cro%%lan+" Le*i%J% Pharmacolo,& Churchil Li)in,%tone.

01( Po%e-h T. Di-iro" Pharmacothera-&?A -atho-h&%iolo,ical a--roach

03( Crai," Charle% R." $o+ern Pharmacolo,& *ith clinical a--lication%

04( .L. Sharma" Princi-le% of Pharmacolo,&

0B( .D. Tri-athi" E%%ential% of $e+ical Pharmacolo,&

0." Li--ncottJ% Illu%trate+ Re)ie* of Pharmacolo,&

-S@"CS-

0( htt-@@***.emcell.com@en@li%tXofX+i%ea%e%@+ia5ete%Xtreatment.htm

0( htt-@@***.emcell.com@en@li%tXofX+i%ea%e%@-ar7in%onXtreatment.htm

0/( htt-@@r%t5.ro&al%ociet&-u5li%hin,.or,@content@1B4@/41


58/90

C " S#$# "%&'S&TY

*$D#*$% C&TY

%ame o! Faculty Pharmaceutical Science

Proposed Sylla0i !or

Master in Pharmacy

Semester-&&

%ame o! Discipline

0/1( Pharmaceutics

0/3( Pharmaceutical Technology

0/4( uality $ssurance

0/B( Pharmaceutical $nalysis

0/


59/90

Teaching Scheme

(#ours8*ee;)

Theory

SessionalExam

UniversityExam

Marks Hrs Marks Hrs

/

PG$P0/Dru, Re,ulator& A%-ect%

IPR

3 ? ? 3 3 1 /.4


60/90

lic. for te%tin, of +ru,% an+ APIJ%" $f,." Contract an+ Loan licen%e

manufacturin,.

0

2

$ppro6al o! %e+ drugs

In)e%ti,ational Ne* Dru, 'IND( %u5mi%%ion" format content of IND"

content of In)e%ti,ator 8rochure" ,eneral con%i+eration of Ne* Dru,

A--ro)al 'NDA(" %-ecific re9uirement%" content format of NDA"

manufacturin, control re9uirement of NDA,

/:

0

3

Drug egulatory $spects (&nternational highly regulated mar;ets)

/. US Re9uirement% 'for Generic Dru,% e%-eciall& formulation%(.

0. CTD Format% of +o%%ier%" E?%u5mi%%ion" US D$F ')ariou% t&-e%(" IIG

Limit%" r-han Dru,%" )anilla ANDAJ%" e6hi5it@-i)otal 5atche%" )ali+ation

5atche%" )ariou% ,ui+ance i%%ue+ 5& CDER" OGD" Oran,e 8oo7 'an+

-atent%(" RLD 'reference li%te+ +ru,( for 8E %tu+ie% an+ the norm% for

US %u5mi%%ion" 5ioe9ui)alence an+ +i%%olution recommen+ation%"

-ac7a,in," %ta5ilit& %tu+ie% an+ the -ro+uct information leaflet" US FDA

in%-ection 'au+it%(" -re?a--ro)al in%-ection% an+ a--ro)al%.

1. Euro-ean Union Re9uirement%

3. All the a%-ect% for Euro-ean re,i%tration of formulation% for ,eneric

+ru,% %ale in the Euro-ean mar7et% un+er EU. E$EA ,ui+eline% on

)ariou% a%-ect% a% a5o)e 'C /(.

4. A 5rief intro+uction to the ,ui+eline% for >a-an" Au%tralia" South Africa"

Re%t of the #orl+ 'RO#( an+ South Latin American countrie%.

, G$P au+it%" role of 9ualit& a%%urance" -ro+uct a--ro)al% an+ %u--lie%.

/3

0

4

Intro+uction to IPR Patent% De)elo-ment of IP la* in In+ia" IPR re,ime"

intro+uction to IP la*% in In+ia" Intro+uction" -atent le,i%lation" In+ian

Patent% Act /


61/90

Patent %earch" -atent anal&%i% -atent +raftin,.

Allie+ Patent% Relate+ I%%ue% E6-loitation of -atent" a5u%e of

-atent%" com-ul%or& licen%in," infrin,ement anal&%i%" +ru,?-atent lin7a,e.

0

5

International treatie% an+ con)ention% on IPR ? Pari% con)ention" PCT an

intro+uction" PCT a--lication ,eneral rule%" #TO @ GATT %&%tem

Uru,ua& TRIPS" #IPO. atch #a6man Act an+ amen+ment%" FDA

$e+icare $o+erniation Act" 01. Intro+uction to ,eo,ra-hical

in+ication@tra+emar7@co-&ri,ht filin, -roce+ure%.

/:

0

6

IPR an+ Pharmaceutical Re%earch

8enefit% of IPR% to im-ro)e the 9ualit& of re%earch *or7 Strate,ie% for

a)oi+in, re%earch +u-lication%" infrin,ement%

:3

Total :

E$%&%. @"TC@MS

000( To ,et familiar *ith re,ulator& a%-ect% relate+ to Re%earch

De)elo-ment a% *ell a% manufacturin, an+ mar7etin, of Pharmaceutical Pro+uct%


001( The cour%e em-lo&% lecture% an+ cla%% +i%cu%%ion%. It al%o inclu+e%

-re%entation 5& %tu+ent% on a %-ecific to-ic a%%i,ne+ to them 5& the facult&.


62/90

. I. anfer L. Shar,el" Generic Pro+uct De)elo-ment 8E i%%ue+ Informa

ealthcare.

/. Pharmaceutical Pro+uct De). I!I!C 5& $urth&" Sun7ara an+ Da)i+

//. USPTO an+ #IPO Gui+eline%.

/0. Gnarino Richar+ A" Ne* Dru, A--ro)al Proce%%" 1 r+ E+." $arcel De77er Inc.

-S@"CS

003( ***.mohf*.nic.in

004( ***.u%f+a.,o)

00B( ***.mhra.,o).u7

00


63/90

@


64/90

3 &ndustrial-institution interaction? In+u%trial -ro;ect%" their" fea%i5ilit&

re-ort%. Interaction *ith in+u%trie%.

3

4 thical issues in research

i%torical -er%-ecti)e%" General -rinci-le% on ethical con%i+eration

in)ol)in, human -artici-ation" General ethical e)aluation of +ru,%@

+e)ice@ +ia,no%tic%@)accine%@ her5al reme+ie%.

Statement of %-ecific -rinci-le% for human ,enetic% an+ ,enomic re%earch.

International Conference on armoniation. Goo+ clinical -ractice%

norm%" Ethical -rinci-le% relate+ to animal e6-eriment%.

/0

5 Cost analysis Funding 8 Scholarship

Co%t anal&%i% of the -ro;ect co%t incurre+ on ra* material%? Proce+ure"

in%trumentation% an+ clinical trial%. A,encie% 'international a,encie%"

Go)ernment an+ -ri)ate 5o+ie%.( fun+in, re%earch in -harmaceutical

%cience%" Scholar%hi-" t&-e% of %cholar%hi-% in e+ucation.

ame% Cro%%lan+" Le*i%J% Pharmacolo,& Churchil Li)in,%tone.

14( Po%e-h T. Di-iro" Pharmacothera-&?A -atho-h&%iolo,ical a--roach

1B( Crai," Charle% R." $o+ern Pharmacolo,& *ith clinical a--lication%

1

proposed structure for master of pharmacy degree-02!09!13

Documents